Prospective Multicenter Study of Bronchiolitis Admissions: Etiology & Disposition

毛细支气管炎入院的前瞻性多中心研究：病因学

基本信息

批准号：
7489336
负责人：
CARLOS A. CAMARGO
金额：
$ 88.37万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-01 至 2011-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7489336
关键词：
Accident and Emergency department Accounting Address Adenoviruses Admission activity Advanced Development Air Area Birth Bordetella pertussis Bronchiolitis Caring Child Child health care Childhood Clinical Clinical Data Clinical Research Cohort Studies Confidence Intervals Consensus Continuous Positive Airway Pressure Coronavirus Data Diagnostic Disease Emergency Medicine Emergency Situation Enrollment Etiology Family Fostering Guidelines Healthy People 2010 Hospitalization Hospitalized Child Hospitals Hour Human Metapneumovirus Hydration status Infant Infection Influenza Inpatients Intensive Care Intensive Care Units Intubation Judgment Knowledge Laboratories Length of Stay Lung diseases Medical Methods Modeling Monitor Multicenter Studies Mycoplasma pneumoniae Nutritional Organism Outcome Oxygen Parainfluenza Parents Physicians Process Public Health Randomized Controlled Clinical Trials Research Research Personnel Respiratory physiology Respiratory syncytial virus Rhinovirus Risk Role Sampling Services Short-Term Course Supportive care Testing Therapeutic Intervention Time Transportation Triage United States Week base cost day design follow-up improved pathogen patient safety prospective respiratory ward

项目摘要

DESCRIPTION (provided by applicant): Specific Aims: Bronchiolitis is the leading cause of hospitalization for infants, but there is a lack of consensus about optimal management. The proposed study has 3 specific aims to address this knowledge gap: 1) To elucidate the role of multiple pathogen infections and to determine the utility of PCR-testing for an infectious etiology. 2) To create high-risk and low-risk clinical rules to predict reliably those children with bronchiolitis who would require continuous positive airway pressure or intubation and those who would not require intensive care. 3) To develop hospital discharge guidelines that encourage earlier, but safe discharges and foster family-centered care. Design: We will conduct a prospective multicenter cohort study. Over a 3-year period, researchers at 15 hospitals will enroll and have 1-week follow-up for 2,250 children < 2 years hospitalized with bronchiolitis. The study will use the Emergency Medicine Network (EMNet, www.emnet-usa.org), a clinical research network that has completed >20 multicenter studies focusing on respiratory emergencies and public health. Methods: We will collect microbiologic data, demographic, birth, nutritional, family, and environmental information as well as clinical data from the emergency department, medical ward, and intensive care unit. Analysis: When comparing infants with bronchiolitis due to multiple pathogens to those with single or no identifiable pathogen, we will have 80 percent power to detect a 1.4 fold difference in CPAP or intubation and a 1.2 fold difference in mean hospital length-of-stay. Approximately 225 infants will require CPAP or intubation (high-risk outcome), while 1800 will not require intensive care (low-risk outcome). For the less common high-risk outcome, we will use 1/2 of our data to create a clinical prediction rule with up to 11 variables and test the model on the other 1/2 of our data. The tested discharge guidelines will be of sufficient precision based on calculated 95 percent confidence intervals to be useful when making clinical decisions. Relevance: By conducting research how to better treat and manage of one of the most common pediatric illnesses, our aims match well with the Healthy People 2010 focus areas of respiratory disease and maternal, infant, and child health. For children with bronchiolitis, this study will help determine the utility of testing for an infectious etiology, advance the development of evidenced-based management and triage guidelines, and encourage safe early discharges and more family-centered care.

描述（由申请人提供）：具体目标：细支气管炎是婴儿住院的主要原因，但对于最佳治疗缺乏共识。拟议的研究有 3 个具体目标来解决这一知识差距：1) 阐明多种病原体感染的作用并确定 PCR 检测对感染病因的效用。 2) 制定高风险和低风险临床规则，以可靠地预测哪些患有细支气管炎的儿童需要持续气道正压通气或插管，哪些儿童不需要重症监护。 3) 制定出院指南，鼓励尽早安全出院并促进以家庭为中心的护理。设计：我们将进行一项前瞻性多中心队列研究。在 3 年的时间里，15 家医院的研究人员将招募 2,250 名因细支气管炎住院的 2 岁以下儿童，并进行为期 1 周的随访。该研究将使用紧急医学网络（EMNet，www.emnet-usa.org），这是一个临床研究网络，已完成超过 20 项多中心研究，重点关注呼吸系统紧急情况和公共卫生。方法：我们将从急诊科、内科病房和重症监护室收集微生物学数据、人口统计、出生、营养、家庭和环境信息以及临床数据。分析：当将由多种病原体引起的细支气管炎婴儿与患有单一或无可识别病原体的婴儿进行比较时，我们将有 80% 的功效检测到 CPAP 或插管的 1.4 倍差异以及平均住院时间的 1.2 倍差异。大约 225 名婴儿需要 CPAP 或插管（高风险结果），而 1800 名婴儿不需要重症监护（低风险结果）。对于不太常见的高风险结果，我们将使用 1/2 的数据创建最多包含 11 个变量的临床预测规则，并在另外 1/2 的数据上测试模型。经测试的出院指南将具有足够的精度，基于计算出的 95% 置信区间，可在做出临床决策时发挥作用。相关性：通过研究如何更好地治疗和管理最常见的儿科疾病之一，我们的目标与“健康人民 2010”呼吸系统疾病和孕产妇、婴儿和儿童健康的重点领域非常吻合。对于患有细支气管炎的儿童，这项研究将有助于确定感染性病因检测的效用，推进循证管理和分诊指南的制定，并鼓励安全早期出院和更多以家庭为中心的护理。